Australia Life Sciences Market

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1 Australia Life Sciences Market Monique Roos, Commercial Specialist U.S. Commercial Service, Sydney, Australia November 2014

2 Geographical Size

3 Population Density More than 80% of population in this ring

4 Basic Facts Population 23 million World s 12 th largest economy stable political environment & strong economy 23 years of economic growth forecast GDP growth rate 2014: 3% unemployment: 6.0% Relatively strong Australian Dollar but has fallen 11% in the last year exchange rate: AUD1.00 = USD0.87

5 Economic Drivers Located in the world s fastest growing economy region 4 th largest economy in the Asia Pacific region Reliance on mineral and commodity exports

6 U.S.-Australia Trade Relationship U.S./Australia Free Trade Agreement since 2005 January 2015 marks 10 th anniversary of the FTA Our 12 th largest export market Australia buys more goods from the U.S. than from any other country Major Australian trading partners: China, U.S., Japan

7 Australia s Life Sciences Industry Healthcare System Overview Hospitals Health Trends Regulatory Requirements Medical Eq. Pharmaceuticals Complementary Medicines Dental Eq. Biotechnology Health IT Veterinary Eq. Opportunities

8 Healthcare System Overview Mix of public and private sector funding complex mix of public/private reimbursement Government-funded healthcare scheme approx. 50% of Australians have private health insurance Government primary purchaser of medical products 70% of sales to the Public/Government sector 30% of sales to the Private sector Costs of maintaining a public healthcare system is a concern hospital administrators directed to choose the best product available at the lowest cost

9 Healthcare System (cont d) 9.5% of GDP spent on health comparable to United Kingdom, Spain & Greece vs U.S. (17%) High per capita income demand for full range of sophisticated medical equipment Educated population expectation of state-of-the-art treatment

10 Hospitals 750 public; 590 private Public hospitals large, more complex care intensive care, emergency, major surgery, organ transplants, renal dialysis and specialist outpatient clinics Private hospitals less complex non-emergency care 67% of admissions involving elective surgery shift and now providing more complex services e.g. intensive care, cardiac & oncology units

11 Health Trends Life expectancy is among the highest in the world 80 yrs men; 84 yrs women Leading causes of death include cancer and circulatory system diseases such as heart disease 2012: 63% of adult Australians were overweight or obese Obesity s growing prevalence foreshadows increases in the occurrence of chronic conditions such as diabetes, asthma, and higher healthcare costs

12 Regulatory Requirements Therapeutic Goods Administration (TGA) Regulation of medical devices based on the Global Harmonization Task Force (GHTF) model and closely aligned with the European Union (EU) system for medical devices no recognition of FDA product approvals firms should obtain CE Mark prior to exporting to Australia Australian Sponsor applies for TGA approval and listing of product on the Australian Register of Therapeutic Goods (ARTG)

13 Medical Eq. Ninth-largest export market for U.S. medical products more than 95% of medical devices are imported approx. 60% of these products are from the U.S. other main sources include Germany & Ireland Mature market for medical products sophisticated, competitive & price-sensitive new to market companies may experience strong competition from other U.S. companies or multinationals already in the market

14 Pharmaceuticals One of the top areas of business investment in Australian R&D Australia often chosen by global medicines industry to conduct clinical trials industry is the largest high-technology exporter Pharmaceutical Benefits Scheme (PBS) patients pay $32.00 or $6.00 for concession card holders Federal Govt. subsidizes remaining cost listing involves a rigorous clinical and cost-effectiveness evaluation against already available alternatives Most prescribed medicines broadly reflects the burden of disease in Australia cardiovascular, glaucoma, cancer, respiratory disorders, mental illness, auto immune disorders, high blood pressure, cholesterol

15 Complementary Medicines Complementary Medicines vitamin, mineral, plant or herbal, naturopathic and/or homeopathic preparations some aromatherapy preparations, and nutritional supplements Sophisticated and competitive market 254 complementary medicine companies and 59 manufacturing facilities Australian firms export to more than 20 countries 10,000 complementary medicines on the market 1,800 new complementary medicines listed on the ARTG each year Ageing population a move towards pro-active healthcare & preventative therapy growing popularity of integrated medicines where East meets West. growth categories: provide scientific evidence to support efficacy; products aimed at the ageing baby boomer market; products that help people maintain their health

16 Complementary Medicines Regulation Regulated as medicines evidence of pharmaceutical GMP Lower risk medicines Listed on the ARTG (Aust L) Assessed for quality and safety but not efficacy Only contain low risk, pre-approved ingredients Not make any indications (therapeutic use) for the treatment of a disease or condition Sponsor must certify they hold evidence to support indication and claims High risk medicines Registered on the ARTG (Aust R) Assessed for quality, safety & efficacy

17 Dental Eq. Dependent on imported products market is mature, sophisticated and competitive strong demand for full range of innovative products local manufacturing < than 3% of dental products sold United States is second-largest supplier after Germany Opportunities state of-the-art dental technology; products for ageing population; and cosmetic & preventative procedures

18 Biotechnology Approx. 420 biotechnology companies agricultural biotechnology, biomedicines, biopharmaceuticals, stem cell sciences, environmental biotechnology and diagnostics biomedical strongest sub-sector with well established focus on therapeutics, diagnostics & vaccines world-class science and medical research, & capacity for international partnerships Scientific American Worldview Scorecard 2014 ranks Australia as number four in the world for biotechnology innovation measures countries biotech performance according to productivity, intellectual property protection, intensity, enterprise support, education/workforce, foundations, and policy and stability Emerging trends foodtech and cleantech

19 Health IT Government s National E-Health Strategy National E-Health Transition Authority (NEHTA) - personally controlled electronic health records (PCEHR) 2012 Pursuing solutions to grow a sustainable healthcare system improve health outcomes and respond to increasing cost & demand pressures; greater demand for personalized care; and an ageing population health system serves urban centers, remote and rural areas, and indigenous communities across a vast geographic region solutions need to be integrated and interoperable with the current architecture

20 Veterinary Eq. Sophisticated market for animal health products More than 66% of Australians own pets APVMA - Australian Pesticides and Veterinary Medicines Authority (APVMA): Veterinary chemicals: prevent, diagnose, cure or alleviate a disease, condition cure or alleviate an injury; modify the physiology incl. vitamins, minerals and additives if they are used for above AQIS Australian Quarantine and Inspection Service Import permit required for: Animal Feed - including pet food & treats, stock feed, aquaculture feed, and bait Veterinary Products - such as therapeutics and medicines

21 Opportunities Technology & Products: significantly improve clinical outcomes and/or reduce costs serve an ageing population high level of uptake of innovative technology Many clinicians have spent time in the U.S. Australia s chronic disease burden is similar to the U.S.: asthma, cancer (incl. lung, colorectal), type 2 diabetes, coronary heart disease, stroke, arthritis, osteoporosis, depression, chronic obstructive pulmonary disease (COPD), chronic kidney disease, oral disease Continuing need for high quality & innovative medical equipment and products innovative and high-quality U.S. products are well-received

22 Contact Us U.S. Commercial Service Level 59 MLC Centre, Martin Place Sydney NSW 2000 Australia Tel: monique.roos@trade.gov

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